EPA intends to limit which scientific studies it will consider, which could undermine settled conclusions about the health impacts of air pollution. This is Part 1 of 4. Click to read Part 2 about the so called “secret science” proposed rule, Part 3 discussing comments by public health experts, and Part 4 on what the final rule’s downfall means for the Biden EPA.
EPA has historically relied on the best available peer-reviewed science to carry out its mission. Federal law requires that EPA consider all available information in its decision-making. Yet, in a recent interview Administrator Pruitt said that he would announce a policy to exclude critical science from being considered by EPA. Under this policy, EPA could only consider scientific studies if the underlying data are made public in a way that would allow independent researchers to reproduce the results.
Administrator Pruitt argues that the proposal is necessary to achieve transparency and validate the underlying science. But peer-review within the scientific community already meets these goals. EPA’s Peer Review Policy sets the expectation that EPA will use the best available science, relying on the professionally-developed peer-review process to ensure its credibility. Pruitt’s announcement begs the question: why is he trying to solve a problem that was solved by scientists themselves long ago?
Targeting Critical Public Health Studies
Administrator Pruitt appears to be targeting long-standing science that underlies EPA’s air quality protection programs. In particular, the announcement seems aimed at two bedrock studies that found that particle pollution, or soot, harms people’s health: the Harvard Six Cities study and the American Cancer Society’s Cancer Prevention Study II. These two ground-breaking studies followed tens of thousands of people over nearly two decades, and linked personal medical histories, occupational histories, and home locations to detailed air quality data to show that people exposed to more particulate matter are more likely to die prematurely. The researchers made confidentiality agreements with the study participants stating that their private information would not be made public. That promise of confidentiality is part of why EPA would be precluded from considering the studies under the forthcoming policy.
The science underlying these studies has been thoroughly peer-reviewed, and the studies and their results have been replicated by scientists around the world. The nonprofit Health Effects Institute – which has received funding both from EPA and the motor vehicle industry – conducted a thorough reanalysis of the two studies that validated their findings. If “transparency” is the signal of sound science, then peer-review and the replication of experimental results achieves that goal. Under existing practice, EPA can also contact researchers who hold the data to review it for themselves, provided they agree to confidentiality requirements.
Issues with the forthcoming policy
There are at least three big problems with the policy Administrator Pruitt intends to announce.
First, the policy would hamper EPA’s ability to carry out one of its most critical public health duties: conducting the ongoing review of the air quality standards for particulate matter. These national standards (along with standards for five other air pollutants) have been essential to America’s air quality improvements over the past half century. The Clean Air Act requires that EPA look exclusively at health science to set these standards and that the agency review the standards every five years to ensure they track new scientific developments.
Now Administrator Pruitt is proposing to exclude the fundamental science that underpins this public health protection. Distorting the scientific record by excluding studies could enable EPA to relax limits on particulate matter exposure, despite reports that more than 43 million people live in areas where there are too many days of high particle pollution.
Second, this policy would limit what information EPA can consider in other matters. Manufacturers of pesticides and chemicals, for example, are required to submit information to EPA on the toxicity of their products to obtain permission to sell them. This often includes substantial amounts of confidential-business information. Similarly, motor vehicle certifications can include confidential engineering science. The intended policy threatens to hamstring EPA’s ability to work with those industries to register their products for sale. Pruitt could exempt this type of confidential data from the reach of the potential policy, but only if the agency can meet the burden of explaining why these data are distinguishable from the confidentiality concerns underpinning the soot studies.
Third, the policy attacks cost-benefit analysis, a tool the entire government uses to set priorities, provide information to decision makers, and develop regulations. The policy would make it harder to justify taking action to protect public health, because it would exclude from consideration the studies that help scientists quantify the benefits of pollution reductions. A longstanding Executive Order mandates that all executive agencies undertake cost-benefit analysis as part of the regulatory process. When EPA issues air pollution rules the agency routinely provides the public with detailed analysis that quantifies the economic impact of the regulation, such as reduced asthma attacks, heart attacks, or missed days of school and work.
Scholars have long debated how informative cost-benefit analysis is; it provides a quantitative measure of a policy’s effects, but many benefits are hard to capture using dollars as the measure. In particular, economists have struggled to assign value to health benefits, meaning that cost-benefit analysis is often skewed towards showing more easy-to-measure costs with relative precision, while understating the monetary value of the full range of benefits. Still, because so much policy analysis relies on cost-benefit analysis, most agencies and administrations have worked to find ways to overcome these limitations – as opposed to compounding them, which is what the Pruitt policy promises to do.
The two studies that Pruitt’s policy threatens prove that particulate matter pollution causes premature death, and show the marginal impact of increased pollution. With that information, combined with an estimate of the societal cost of premature death, EPA can quantify the health benefits from its air pollution rules. Thanks to these studies, the benefits from avoided mortality due to reductions in particulate matter make up the vast majority of the quantified benefits of EPA air pollution rules.
Excluding these studies would prevent the cost-benefit analysis from quantifying the relevant health benefits for any rule that incidentally reduces particulate matter pollution – such as the Clean Power Plan or rules governing fuel economy of cars. This would tip the scales of cost-benefit analysis, and provide EPA with the results needed to justify inaction on dangerous pollution.
In addition to undermining EPA’s mission, Pruitt’s statements and pending action raise a set of challenges to his fellow agency and cabinet department heads. Many agencies rely on physical science, public health science, and engineering studies as well as cost-benefit analysis to do their work in safeguarding the public or otherwise advancing the public interest. Do they agree with Mr. Pruitt and the impending exclusion of the category of studies covered by his new policy? If so, are they planning to follow suit, and what would be the policy and legal consequences be if they did?
EPA did publish a proposed rule following this post. Click to read Part 2 and Part 3 in this series for more information. For more information on other changes to science at EPA, please see our other Mission Tracker posts, including:
- Removing Academic Scientists from Advisory Panels
- Results-Oriented Regulatory Science
- Our post and podcast on EPA’s modifications to the national air quality standards five-year review process
This post was updated on Jan. 16, 2020 as part of EELP’s ongoing effort to standardize the Mission Tracker.